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• Enalapril Astimex ENG PL

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Package leaflet: Information for the user

Enalapril Astimex 2.5 mg, 5 mg, 10 mg, or 20 mg tablets

enalapril maleate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Enalapril Astimex is and what it is used for

2. What you need to know before you take Enalapril Astimex

3. How to take Enalapril Astimex

4. Possible side effects

5. How to store Enalapril Astimex

6. Contents of the pack and other information

1. What Enalapril Astimex is and what it is used for

Enalapril Astimex contains an active substance called enalapril maleate. This belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).

Enalapril Astimex is used:

• to treat high blood pressure (hypertension)

• to treat heart failure (weakening of heart function). It can lower the need to go to hospital and can help some patients live longer

• to prevent the signs of heart failure. The signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet.

Enalapril Astimex works by widening your blood vessels. This lowers your blood pressure. The medicine usually starts to work within an hour, and the effect lasts for at least 24 hours. Some people will require several weeks of treatment until the best effect on your blood pressure is seen.

2. What you need to know before you take Enalapril Astimex

Do not take Enalapril Astimex

• if you have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited.

• if you are more than 3 months pregnant (it is also better to avoid Enalapril Astimex in early pregnancy, see Pregnancy section.).

• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Do not take Enalapril Astimex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Enalapril Astimex.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril Astimex if:

• you have a heart problem

• you have a condition involving the blood vessels in the brain

• you have a blood problem such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or a decreased number of red blood cells (anemia)

• you have a liver problem

• you have a kidney problem (including kidney transplantation). These may lead to higher levels of potassium in your blood which can be serious. Your doctor may need to adjust your dose of Enalapril Astimex or monitor your blood level of potassium.

• you are having dialysis

• you have been very sick (excessive vomiting) or had bad diarrhoea recently

• you are on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes

• you are over 70 years of age

• you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. The level of potassium in your blood can also be higher.

• you have ever had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing. You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.

• you have low blood pressure (you may notice this as faintness or dizziness, especially when standing)

• you have collagen vascular disease (e.g. lupus erthematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses your immune system, are taking the drugs allopurinol or procainamide, or any combinations of these.

• you think you are (or might become) pregnant. Enalapril Astimex is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Pregnancy section).

• you are breast-feeding or about to start breast-feeding (see Breast-feeding section).

• if you are taking the following medicines used to treat high blood pressure:

- an angiotensin II receptor blocker (ARBs) (also known as sartans – for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

- aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Enalapril Astimex if”

You should be aware that Enalapril Astimex lowers the blood pressure in black patients less effectively than in non-black patients.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Enalapril Astimex.

If you are about to have a procedure

If you are about to have any of the following, tell your doctor that you are taking Enalapril Astimex:

• any surgery or receive anaesthetics (even at the dentist).

• a treatment to remove cholesterol from your blood called ‘LDL apheresis’

• a desensitization treatment, to lower the effect of an allergy to bee or wasp stings.

If any of the above apply to you, talk to your doctor or dentist before the procedure.

Other medicines and Enalapril Astimex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Enalapril Astimex can affect the way some medicines work. Also some other medicines can affect the way Enalapril Astimex works.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Enalapril Astimex if” and “Warnings and precautions”).

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines to lower blood pressure, such as beta-blockers or water tablets (diuretics)

• medicines containing potassium (including dietary salt substitutes)

• medicines for diabetes (including oral antidiabetic medicines and insulin)

• lithium (a medicine used to treat a certain kind of depression)

• medicines for depression called ‘tricyclic antidepressants’

• medicines for mental problems called ‘antipsychotic’

• certain cough and cold medicines and weight reducing medicines which contain something called a ‘sympathomimetic agent’

• certain pain or arthritis medicines including gold therapy

• non-steroidal anti-inflammatory drugs, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain).

• aspirin (acetylsalicylic acid)

• medicines used to dissolve blood clots (thrombolytics)

• alcohol.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Enalapril Astimex.

Enalapril Astimex with food and drink

Enalapril Astimex can be taken with or without food. Most people take Enalapril Astimex with a drink of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking Enalapril Astimex before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril Astimex. Enalapril Astimex is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Enalapril Astimex. In the case of an older baby your doctor should advise you on the benefits and risks of taking Enalapril Astimex whilst breast-feeding, compared to other treatments.

Driving and using machines

You may feel dizzy or sleepy while taking Enalapril Astimex. If this happens, do not drive or use any tools or machines.

Enalapril Astimex contains lactose

Enalapril Astimex contains lactose, which is a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Enalapril Astimex

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• It is very important to continue taking Enalapril Astimex for as long as your doctor prescribes it.

• Do not take more tablets than prescribed.

High Blood Pressure

• The usual starting dose ranges from 5 to 20 mg taken once a day.

• Some patients may need a lower starting dose.

• The usual long term dose is 20 mg taken once a day.

• The maximal long term dose is 40 mg taken once a day.

Heart Failure

• The usual starting dose is 2.5 mg taken once a day.

• Your doctor will raise this amount step by step until the dose that is right for you has been achieved.

• The usual long term dose is 20 mg each day, taken in one or two doses.

• The maximal long term dose is 40 mg each day, divided in two doses.

Patients with kidney problems

Your dose of medicine will be changed depending on how well your kidneys are working:

• moderate kidney problems - 5 mg to 10 mg each day

• severe kidney problems - 2.5 mg each day

• if you are having dialysis - 2.5 mg each day. On days you are not having dialysis, your dose may be changed depending on how low your blood pressure is.

Elderly patients

Your dose will be decided by your doctor and will be based on how well your kidneys are working.

Use in children

Experience in the use of Enalapril Astimex in children with high blood pressure is limited. If the child can swallow tablets, the dose will be worked out using the child’s weight and blood pressure. The usual starting doses are:

• between 20 kg and 50 kg - 2.5 mg each day

• more than 50 kg - 5 mg each day.

The dose can be changed according to the needs of the child:

• a maximum of 20 mg daily can be used in children who are between 20 kg and 50 kg

• a maximum of 40 mg daily can be used in children who are more 50 kg.

Enalapril Astimex is not recommended in newborn babies (first few weeks after birth) and in children with kidney problems.

If you take more Enalapril Astimex than you should

If you take more Enalapril Astimex than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: feeling of light‑headed or dizziness. This is due to a sudden or excessive drop in blood pressure.

If you forget to take Enalapril Astimex

• Take the next dose as usual.

• Do not take a double dose to make up for a forgotten dose.

If you stop taking Enalapril Astimex

Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking Enalapril Astimex and talk to a doctor straight away, if you notice any of the following:

• swelling of your face, lips, tongue or throat which may cause difficulty in breathing or swallowing.

• swelling of your hands, feet or ankles

• if you develop a raised red skin rash (hives).

You should be aware that black patients are at increased risk of these types of reactions. If any of the above happen, stop taking Enalapril Astimex and talk to a doctor straight away.

When you start taking Enalapril Astimex you may feel faint or dizzy. If this happens, it will help to lie down. This is caused by your blood pressure lowering. It should improve as you continue to take the medicine. If you are worried, please talk to your doctor.

Other side effects include:

Very Common (affects more than 1 in 10 people)

• feeling dizzy, weak or sick

• blurred vision

• cough.

Common(affects less than 1 in 10 people)

• low blood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain

• headache, fainting (syncope)

• change in sense of taste, shortness of breath

• diarrhoea or abdominal pain, rash

• tiredness (fatigue), depression

• allergic reactions with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing

• increased blood potassium level, increased levels of creatinine in your blood (both are usually detected by a test).

Uncommon (affects less than 1 in 100 people)

• sudden fall in blood pressure

• fast or uneven heart beats (palpitations)

• heart attack (possibly due to very low blood pressure in certain high-risk patients, including those with blood flow problems of the heart or brain)

• anaemia (including aplastic and haemolytic)

• stroke (possibly due to very low blood pressure in high-risk patients)

• confusion, sleeplessness or sleepiness, nervousness

• feeling your skin prickling or being numb

• vertigo

• ringing in your ears (tinnitus)

• runny nose, sore throat or hoarseness

• asthma

• s low movement of food through your intestine, inflammation of your pancreas

• being sick (vomiting), indigestion, constipation, anorexia

• irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure

• increased perspiration

• itching or nettle rash

• loss of hair

• muscle cramps, flushing, generally feeling unwell (malaise), high temperature (fever), impotence

• high level of proteins in your urine (measured in a test)

• low level of blood sugar or sodium, high level of blood urea (all measured in a blood test).

Rare (affects less than 1 in 1,000 people)

• ‘Raynaud’s phenomenon’ where your hands and feet may become very cold and white due to low blood flow

• changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets

• bone marrow depression

• autoimmune diseases

• strange dreams or sleep problems

• pulmonary infiltrates

• inflammation of your nose

• pneumonia

• inflammation of the cheeks, gums, tongue, lips, throat

• lower amount of urine produced

• erythema multiforme

• ‘Stevens-Johnson syndrome’ a serious skin conditions where you have reddening and scaling of your skin, blistering or raw sores, or detachment of the top layer of skin from bottom layers

• liver problems such as lower liver function, inflammation of your liver, jaundice (yellowing of the skin or eyes), higher levels of liver enzymes or bilirubin (measured in a blood test)

• enlargement of the mammary glands in males.

Very Rare (affects less than 1 in 10,000 people)

Reporting of side effects

If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
[*To be completed nationally]

5. How to store Enalapril Astimex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.

Do not store Enalapril Astimex above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Enalapril Astimex contains

• The active substance is enalapril maleate (either 2.5 mg, 5 mg, 10 mg, or 20 mg).

• The other ingredients are lactose mono hydrate, sodium hydrogen carbonate, magnesium stearate, corn starch and pre-gelatinised maize starch. The 10 mg and 20 mg tablets also contain iron oxide red (E172).

What Enalapril Astimex looks like and contents of the pack

Enalapril Astimex is available in four strengths.

• Enalapril Astimex 2.5 mg: White, round, biconvex tablets with break line on one side. Diameter 8.0 mm.

• Enalapril Astimex 5 mg: White, round, biconvex tablets with break line on one side. Diameter 10.3 mm. The tablets can be divided into two equal parts.

• Enalapril Astimex 10 mg: Pink, round, biconvex tablets with four-piece break line on one side. Diameter 8.0 mm.

• Enalapril Astimex 20 mg: Pink, round, biconvex tablets with four-piece break line on one side. Diameter 10.3 mm. The tablets can be divided into four equal parts.

Enalapril Astimexis available in the following pack sizes:

Enalapril Astimex 2.5mg: 10, 14, 28, 50x1 and 98 tablets.

Enalapril Astimex 5mg: 10, 28, 50x1 and 98 tablets.

Enalapril Astimex 10mg: 10, 14, 28, 50x1 and 98 tablets.

Enalapril Astimex 20mg: 28, 50x1 and 98 tablets.

Packs with 14, 28 and 98 are calendar packs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Dexcel Pharma Limited

7 Sopwith Way,

Drayton Fields, Daventry,

Northamptonshire NN11 8PB

UK

Information is provided by:

Astimex pharma AB

Isafjordsgatan 36

164 40 Kista, Sweden

Manufacturer:

Astimex pharma AB

Isafjordsgatan 36

SE-164 40 Kista

Sweden

This leaflet was last revised in